Welcome to gmp training on the topic of documentation requirements. Good recordkeeping not only helps you during regulatory inspections gmp audits, it is mandatory to ensure your documentation practices and your products meet industry standards and legal requirements for safety, efficacy and product quality. Good documentation practice gdp or gdocp, a term used in the pharmaceutical industry, is essential for the integrity of data collection and reporting for supporting development, registrations, commercialization, and lifecycle management of pharmaceutical products. This book is written for the industry that develops, manufactures, and markets medical products for human and veterinary use. This white paper describes the fundamental requirements of good documentation practice gdp routinely used within the pharmaceutical industry as best practice standards or as a direct requirement of the code of good manufacturing practice. Good documentation practice zenosis learning for life. Acronym for the group of good practice guides governing the preclinical, clinical, manufacturing. Phil management senior chemist, albert david limited.
Training is the biggest source to plug in mistakes in industry and biggest source of errors too. Manostaxx indusrial management consulting the definition of good documentation practice gdp describes standards by which. Documentation practices and records control about this document. Data management best practices evaluation checklist. Anas principles for nursing documentationidentifies six essential. Dec 22, 2016 in this course on good documentation practices for the life sciences you will learn all about the basics of working with documents in a regulated environment. Objectives recognize the importance of methodical and organized documentation in research become familiar with record retention requirements.
Learn how to follow good documentation practices in pharmaceutical quality assurance, quality control and production. How to prevent 483 items related to data documentation. Data management best practices evaluation checklist this checklist is designed to help you evaluate your data management activities within your research projects by providing a list of common data management best practices. Good documentation practices pharmaceutical analysis for. Good study documentation will allow for an individual with basic knowledge of the particular project to recreate the events of the study. Good documentation practices known as gdocp vs gdp, which stands for good distribution practices, are an imperative part of assessing risks and managing production quality to gmp eu gmp, pics and other industry standards. Usp chapter good documentation guideline is a general chapter in us pharmacopeia that covers the usp chapter and all aspects of gdp including practices for writing and correcting documentation. Main reason for that is the expert or individual who is responsible would like to write or give a checklist as per his or her knowledge. Good documentation practice gdp, standard operating procedures sops, pharmaceutical industry i. Users dont want documentation, they want answers is a wellknown phrase in the documentation profession. Gdps apply to everyone who documents activities related to cgmp or current good. Correct the errors properly report the deviations if any and implement the capa train all.
R esponsibilities the responsible parties for implementation of this sop are. Documentation basics that support good manufacturing practices and quality system regulations carol desain on. For this reason, good documentation practices commonly referred to as gdpsare critical. Inadequate and poor documentation practices may result citations in the form of fdas 483 observations andor warning letters. Observations on poor documentation practices missing signature and dates at the time of.
Batch manufacturing records bmr batch packing records bpr forms for recording data. The basic rules in any good manufacturing practice gmp regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation practices in research, the only thing that remains to attest to our efforts is the documentation. Scope this procedure applies to all personnel responsible for quality system and business records at affected. The purpose of this standard operating procedure sop is to provide to all employees good documentation practices gdp requirements. Documentation practices and records control about this. An overview of good documentation practices applicable to those working in the pharmaceutical and healthcare sectors is presented.
All entries, except ipqa, should be made with blue ball pen in clear and legible handwriting. Participants will learn which systems require documentary. Good manufacturing practice gmp for medicinal products relies on documentation. Find out what is the most common shorthand of good documentation practices on. Gdp good documentation practices quality support group. This training session will cover the us pharmacopeia general chapter. Good documentation practice gdocp is that part of gmp that applies to the creation, maintenance, use, and retention of documents to provide assurance of the quality of products. The department of medicine clinical research unit has prepared this document is to provide guidance to all faculty and staff involved in the conduct of research on the best practices related to documentation. Pdf the effective control and management of documentation is a critical part of the gmp program within the organization. Records and reports, along with procedures, tell the story of manufactured products and devices.
Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with gmp requirements. Good documentation practices gdocp are key components of gmp compliance. Elements of good documentation a tip sheet for documenting social work service delivery in order to comply with cfsa requirements and best practice standards it is important to document all client contacts, assessments, and the delivery of case management services. Clearly written documents prevent errors of various activities in pharma each and every activity is written in specific documents such as sops and strictly followed.
Create database software based or manual system to. Good documentation practices gdp in pharmaceuticals. Quality risk management to ensure good data management 177 6. The documentation practices that enhance study integrity, repeatability. Good documentation practices for manualpaper documentation. What is the abbreviation for good documentation practices. Why glp serves as a good foundation for clinical studies, gmp, and even research. A complete guide to document development and management of gmp and iso 9000 compliant industries carol desain on. Good documentation practices gdocp and gdp training. Documentation control is not optional it is a legal requirement.
Consequences of both may be time consuming and costly including time spent in responding to the observations and potentially making some operational changes. Pdf good documentation practices tim sandle academia. Article 47 of directive 200183ec on the community code relating to medicinal products for human use and article 51 of directive 200182ec on the community code relating to veterinary medicinal products. Feb 24, 2018 good documentation practices training ppt. All documentation entries shall be made with indelible black ink in clear and legible handwriting. Coordinate regulatory requirements in pharmaceutical manufacturing industry joymalya bhattacharya, m. Good manufacturing practice medicinal products for human and veterinary use chapter 4. Ensuring there is a controlled, documented system to manage gmp related documents and records in compliance with local regulations. Such measures that collectively and individually ensure documentation, whether paper or electronic, is attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate. However, there is no code of federal regulations for gdp. This standard operating procedure is applicable to all departments involved in documentation activities throughout the facility of pharmaceutical company name. Looking for the abbreviation of good documentation practices. Documentation legal basis for publishing the detailed guidelines.
Standardization of data and documentation practices for. Good documentation practices if you didnt document it, you didnt do it. Documentation standards and best practices november 2016 4 the treatment plan a treatment plan is a written document that. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Foundation of a sound documentation system begins with the engineering documents as well as their management. This webinar will familiarize participants with usp chapter. Verification of the document made by qa by using indelible blue ink. Though documentation on construction projects costs money to prepare and maintain, construction documentation has become as essential to completion of a successful construction project as the plans and specifications pursuant to which the job is built. Pdf good documentation practices gdps in pharmaceutical. Good documentation practice documentation is a record of our product history. Good documentation guideline us pharmacopeia general. Bad documentation practice signing for work prior to that work being performed example.
Standardization of data and documentation practices for product tracing guidance for industry february 2018. Designing and validating systems to assure data quality and reliability 183 11. One might assume that a quick visit to the fda website would produce the list of practices. Good documentation answers the questions that people ask.
Best practices enable the proper organization, documentation, and preservation of data. This course guides the participant through the process of setting up a documentation system that meets regulatory requirements and serve its business purpose. Good documentation practices quality assurance documentation. Good documentation practice gap pdf download manoxblog. Training checklist good documentation practice gdocp. Good documentation practices gdps in pharmaceutical. Guide for documenting and sharing best practices in health programmes. Good documentation practice in pharmaceutical industry.
Contracted organizations, suppliers and service providers 180 8. Good documentation practice in pharmaceuticals pharmatutor. Good documentation practice commonly abbreviated gdp, recommended to abbreviate as gdocp to distinguish from good distribution practice also abbreviated gdp is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. Validation is the holdup and everyone just wants to pass the. Requirements for good documentation practice gdp learn all about the good documentation practice including basics, gmp document preparation, issuance and retrieval of records, recording of time, correction of entries, handling of missing entries, blank space and cancellation of gmp records. The webs largest and most authoritative acronyms and abbreviations resource. Why are good documentation practices so important to our customers.
The gdp can be defined as good documentation practice is an essential part of the quality assurance and such, related to all aspects of gmp this definition is based on who. Good documentation practice gdp or gdocp, a term used in the pharmaceutical industry, is essential for the integrity of data collection and reporting for supporting development. This article focuses on the key principles of good documentation practice and offers suggestions for improvement. Suresh what is being made 12272018 2 documentation most of us when attempting a task need some sort of documentation a large part of gmp involves written instructions, following those instructions and making records 12272018 3 documentation. An overview of good documentation practices applicable to those. Documentation basics that support good manufacturing. How to implement good documentation practices pharmout. Gdp good documentation practices course description whether you work in production or in a laboratory, whether you conduct investigations or finalize product release, sound data and information is essential to success and compliance. Good documentation practices quality management system. Engineering is the provider production is the customer qa is the gatekeeper. Good documentation practices good laboratory practices pdf guideline on good pharmacovigilance practices gvp good warehousing practices in pharma ppt a guide to good plumbing practices pdf guide to good plumbing practices from ipa good manufacturing practices guidelines india good practices for consumer protection and financial literacy testing and assessment. Document it and complete the step at that time if possible, noting the actual date it was completed.
This page is updated regularly, therefore, dont forget to visit it again. Good documentation practices ann glasse, rn, bsn, mba director, regulatory support author. The documented cases covered a wide range of subjects, which can be categorised into 3 main themes. Good documentation practices for gxps complianceonline. Article 47 of directive 200183ec on the community code relating to medicinal products for human use and article 51 of directive. Good documentation practices should be everyones concern. Good clinical practice study documentation medicine. To show expert users of windows all the screens that appear during the installation of your product is not necessary. Green ink shall be used only by qa for the issuance of bmr. Address a need for descriptions of what constitutes good documentation records of all types that are clear, accurate, and complete. Good documentation practices and maintaining good customer relations november 14, 2007 presented by john p.
Good documentation practices journal of validation technology. It appears simple and straight forward but for some reason it remains a critical topic in the industry. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This chapter describes the good documentation practices gdocpsgdp and explains why it is important in any regulated environment to manufacture any product. Sep 14, 2017 live webinar recording on good documentation practices sample how to build your own swimming pool. Documentation practices and records control about this document purpose this procedure describes general documentation practices used to complete documents and records and general policies to control those documents and records. Whether on the site or sponsor level, in clinical research we are asked to use good documentation practices gdp during the conduct of a clinical trial. This session will wrap up the general concept and will provide information as to. Correct, complete, current, and consistent information effectively meet customer and stakeholder requirements helps to reduce observations raised on inadequate documentation practices.
Identifies the clients most important goals for treatment describes measurable time sensitive steps toward achieving those goals documents an agreement between the provider and client. Good documentation practices general rules youtube. Abstract the effective control and management of documentation is a critical part of the gmp program. The general application of quality management to pharmacovigilance sys tems is described under i. It provides the minimum requirements for good documentation, the reason why it can help, and the rules one needs to know and abide by when dealing with documentation in a regulated. The documentation should occur at or near the time the services were rendered. Good documentation practice is an expected practice.
Basic rules in any good manufacturing practice gmp regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. The main documentation errors seen and cited by the fda. Good documentation practices gdp these are the articles on good documentation practices in a pharmaceutical manufacturing facility, those are helpful to new as well as experienced pharmaceutical professionals. Good documentation practice in pharmaceutical industry as per eudralex vol 4 principle. Sop on good documentation practices pharmaceutical guidance.
The effective control and management of documentation is a critical part of the gmp program within the organization. Good documentation practice gdp routinely used within the pharmaceutical. It will explain the general concept and will provide information as to what needs to be documented in. Good documentation and record management practices in a gmp. We will look at fda view of documentation specific and ucp documentation practices and practice proper documentation exercises what is the fdas view of documentation. This white paper describes the fundamental requirements of good documentation practice gdp routinely used within the pharmaceutical industry as best practice standards or as a direct requirement of the code of good manufacturing practice gmp.
May 14, 2015 general chapter provides guidelines on how to develop and maintain good documentation practices. All work should be documented at the time work is performed. Pdf on mar 8, 2017, krishan kumar and others published good documentation practices gdps in pharmaceutical industry find, read and. The secret to maintaining good documentation practices. To lay down the procedure for good documentation practices in facility. Usp chapter good documentation guidelines easy global. Afro library cataloguinginpublication data guide for documenting and sharing best practices in health programmes 1.
I am going on break at 10 am and have an observation check due. Compliance with the food and drug administrations glp, or good laboratory practices, regulations 21 cfr part 58, as well as gmp regulations for drugs and medical devices 21 cfr part s 211 and 820 requires the use of good documentation practices. Gdps are enforced by regulatory agencies such as the fda, tga, emea, health canada or who. One of the components of the pils project is the documentation of good practices from local government, village and school levels. Are these standard for iso or just good documentation practices. Documentation helps to build up a detailed picture of what a manufacturing. Good documentation practices gdps in pharmaceutical industry. Good documentation practices have been a hot topic in the medical device industry for a long time.
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